510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k181945 B. Purpose for Submission: Modification of a previously cleared device to add Imipramine and Buprenorphine to the test panel. C. Measurand: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy (MDMA), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Imipramine, Buprenorphine D. Type of Test: Qualitative lateral flow immunoassay E. Applicant: Phamatech, Inc. F. Proprietary and Established Names: QuickScreen Pro Multi Drug Screening Test, Model 9395Z G. Regulatory Information: 1. Regulation section: Product Code Regulation Number Regulation Description DKZ 862.3100 Amphetamine test system DIS 862.3150 Barbiturate test system JXM 862.3170 Benzodiazepine test system DIO 862.3250 Cocaine and cocaine metabolite test system DJC 862.3610 Methamphetamine test system DJR 862.3620 Methadone test system DJG 862.3650 Opiate test system 1 Product Code Regulation Number Regulation Description LCM Unclassified Phencyclidine LDJ 862.3870 Cannabinoid test system LFG 862.3910 Tricyclic antidepressant drugs test system 2. Classification: Class II 4. Panel: Toxicology H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy (MDMA), methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (Imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only. Cut-off Analyte Abbreviation Concentration (ng/ml) Amphetamines AMP 1000 Barbiturates BAR 200 Benzodiazepines BZD 200 Cocaine COC 300 Ecstasy MDMA 500 Methadone MTD 300 Methamphetamine MET 500 Opiates OPI 300 Oxycodone OXY 100 Phencyclidine PCP 25 Marijuana THC 50 2 Cut-off Analyte Abbreviation Concentration (ng/ml) Tricyclic Antidepressants TCA 1000 (Imipramine) (Imipramine) Buprenorphine BUP 10 This test provides only a preliminary test result. A more specific alternate testing method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Other confirmation methods are available. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are observed. 3. Special conditions for use statement(s): For prescription use only 4. Special instrument requirements: Not applicable. These devices are single use and disposable. I. Device Description: The QuickScreen™ Pro Multi Drug Screening Test, Model 9395Z is a competitive immunoassay that is used to screen for the presence of the following drugs of abuse in urine: Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Imipramine, and Buprenorphine. The device is single-use utilizing a cup format. Each kit consists of the following materials: · Twelve separate test strips for the 13 target drugs. Each test strip device includes monoclonal anti-drug antibody/colloidal gold conjugate specific to each drug coated in the sample path, drug derivative/protein conjugate immobilized as a line in the Test Region (T), and goat anti-rabbit antibody immobilized as a line in the Control Region (C). · Instructional insert · Urine sample collection cup · Built-in timer to identify when test test results should be read J. Substantial Equivalence Information: 1. Predicate device name(s): At Home Drug Test 12: Model 9308Z 3 2. Predicate 510(k) number(s): k070009 3. Comparison with predicate: Similarities Item QuickScreen™ Pro Multi At Home Drug Test 12: Drug Screening Test, Model Model 9308Z (k070009) 9395Z Predicate Device Indications for use The QuickScreen™ Pro Multi Same Drug Screening Test Model 9395Z is an screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (Imipramine) and buprenorphine in urine at the cut-off concentrations listed. Methodology Lateral flow immunoassay Same based on the principle of antigen and antibody immunochemistry Results Qualitative Same Analyte Cut-off Amphetamines (AMP): Same for shared analytes 1000 ng/ml Barbiturates (BAR): 200 ng/ml Benzodiazepines: (BZD): 200 ng/ml Cocaine (COC): 300 ng/ml Ecstasy (MDMA): 500 ng/ml Methadone (MTD): 300 ng/ml Methamphetamine (MET): 500 ng/ml Opiates (OPI): 300 ng/ml Oxycodone (OXY): 100 ng/ml Phencyclidine (PCP): 25 4 Similarities Item QuickScreen™ Pro Multi At Home Drug Test 12: Drug Screening Test, Model Model 9308Z (k070009) 9395Z Predicate Device ng/ml Marijuana (THC): 50 ng/ml Tricyclic Antidepressants (TCA): 1000 ng/ml Buprenorphine (BUP): 10 ng/ml Configuration Cup Same Specimen Type Urine Same Use Single-use Same Differences Item QuickScreen™ Pro Multi Drug At Home Drug Test 12: Screening Test Model 9395Z Model 9308Z (k070009) Predicate Device Use Setting Prescription OTC K. Standard/Guidance Document Referenced (if applicable): None referenced. L. Test Principle: TheQuickScreen™ Pro Multi Drug Screening Test, Model 9395Z device employs lateral flow immunochromatographic technology, which involves the recognition and formation of a specific antibody/target drug complex. Drug in the sample and drug-labeled conjugate compete for antibody binding sites. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region (T). The colored line will not form in the test line region if the target drug level exceeds its cutoff- concentration because it will saturate all the binding sites of the antibody coated on the particles. The control line (C) serves as an internal quality control to ensure proper sample volume has been added to the test and that the sample has correctly migrated up the test strip. 5 M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: A precision/reproducibility study was performed using the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device at three separate point of care (POC) sites. Multiple replicates of each of the nine drug concentrations (prepared by spiking negative urine samples with buprenorphine or TCA (Imipramine)) was assayed over a minimum of 5 days. The tests were done in accordance with the package insert instructions using one lot of the device, and a summary of the results are provided in the table below. Precision performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098. Test Results for BUP Level BUP Conc. (ng/ml) % of cutoff Result % Correct (Neg/Pos) 1 0.00 0 80/0 100% 2 2.58 - 75% 80/0 100% 3 5.62 - 50% 80/0 100% 4 7.13 - 25% 80/0 100% 5 10.42 cutoff 0/80 100% 6 12.27 + 25% 0/80 100% 7 16.83 + 50% 0/80 100% 8 17.69 + 75% 0/80 100% 9 20.43 +100% 0/80 100% Test Results for TCA (Imipramine) Level TCA Conc. (ng/ml) % of cutoff Result % Correct (Neg/Pos) 1 0.00 0 80/0 100% 2 249.53 - 75% 80/0 100% 3 547.65 - 50% 80/0 100% 4 767.56 - 25% 80/0 100% 5 1026.32 cutoff 0/80 100% 6 1267.91 + 25% 0/80 100% 7 1589.23 + 50% 0/80 100% 8 1789.60 + 75% 0/80 100% 9 2089.3 +100% 0/80 100% b. Linearity/assay reportable range: Not applicable. 6 c. Traceability, Stability, Expected values (controls, calibrators, or methods): There are no external controls supplied with the device. Real time stability tests were conducted over 24 months. Protocol and acceptance criteria were found to be acceptable. The manufacturer claims that the devices are stable for 22 months. d. Detection limit: See precision data in Section M.1.a., above, for assay performance around the claimed cutoff concentrations. e. Analytical specificity: Cross-reactivity: Cross-reactivity studies for BUP and Imipramine were conducted for the QuickScreen™ Pro Multi Drug Screening Test Model 9395Z device (BUP and TCA) by testing structurally similar compounds. The compounds in the below table were tested for cross reactivity, and the lowest concentration causing a positive result was determined to calculate the percentage of cross-reactivity. Cross-reactivity performance for Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Ecstasy, Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, and Marijuana, was reviewed in k070098. BUP Cross Reactivity Compound Lowest conc. resulting in % cross reactivity positive result Norbuprenorphine 20 ng/ml 50% Morphine N/A <0.01% Buprenorphine-3-ß-D- 10 µg/ml 0.1% Glucuronide Norbuprenorphine-3-ß-D- 20 µg/ml 0.2% Glucuronide Oxymorphone N/A <0.01% Hydromorphone N/A <0.01% TCA Cross Reactivity Compound Lowest conc. resulting % cross reactivity in positive result Amitriptyline 250 ng/ml 400% N-Desmethylclomipramine